| | Class 2 Recall Curlin |  |
| Date Posted |
August 07, 2007 |
| Recall Number |
Z-1129-2007 |
| Product |
Curlin Medical Administration Sets: Model Numbers 340-4111, IV Administration Sets. |
| Code Information |
Model Numbers 340-4111- Lot # D628223, D627616, D620544, D630503; 340-4127- Lot# D620104;
340-4119- Lot# D623716
|
Recalling Firm/ Manufacturer |
Curlin Medical Llc 15751 Graham St Huntington Beach, California 92649-1630 |
| For Additional Information Contact |
Marc Drobnack 714-893-2200 Ext. 141
|
Reason for Recall |
The Administration Sets may leak at the reservior bag.
|
| Action |
A Field Correction Advisory (Recall Letter) was issued on February 9, 2007 to the firm's one US Customer (distributor): B. Braun Medical Inc. recalling Curlin Medical, Inc. Administration Sets 340-4111- Lot # D628223 and D627616 because the affected lots do not meet acceptable performance levels.
A second Field Correction Advisory (Recall Letter) was issued on March 15, 2007 to B. Braun Medical Inc. recalling Curlin Medical, Inc. Administration Sets: 340-4111- Lot # D628223, D6276l6 ,D620544, D630503; 340-4127- Lot# D620104; 340-4119- Lot# D623716 because the affected lots do not meet acceptable performance levels. |
| Quantity in Commerce |
25, 280 |
| Distribution |
One US Customer (distributor): B. Braun Medical Inc. 901 Marcon Blvd. Allentown, PA 18109 |
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